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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K852201
Device Name ECHOCLONAL HCG IRMA
Applicant
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Applicant Contact LYNN C SHANTA
Correspondent
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Correspondent Contact LYNN C SHANTA
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/21/1985
Decision Date 06/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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